Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
FDA Drug Recalls
21 recalls · Class III, newest first
Class III · Low risk
Livalo (pitavatstatin)
Presence of foreign tablets/capsules
Class III · Low risk
Venlafaxine Extended-Release Tablets
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Class III · Low risk
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class III · Low risk
Methotrexate Tablets
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Class III · Low risk
Micafungin for injection
Cross contamination with other products
Class III · Low risk
Micafungin for injection
Cross contamination with other products
Class III · Low risk
Fentanyl 1000mcg/100mL
Labeling: Wrong Barcode
Class III · Low risk
Valacyclovir Tablets USP
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Class III · Low risk
NEXLIZET (bempedoic acid and ezetimibe)
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Class III · Low risk
Votrient (pazopanib)
Failed Dissolution Specifications
Class III · Low risk
Sabril (vigabatrin)
Cross contamination with other products
Class III · Low risk
Bendamustine HCl Injection
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Class III · Low risk
Phytonadione Injectable Emulsion USP
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Class III · Low risk
Crest 3D White Fluoride Anticavity Toothpaste
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Class III · Low risk
Gildess 24 FE 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess FE 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess FE 1/20
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess 1/20
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Remeven Cream
Crystallization; Complaints that cream appears to have crystallized